Kornimate/medical-research-clean huggingface dataset:
correlative analysis of the genomics of vitamin d and omega-3 fatty acid intake in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to see if eating vitamin d, omega 3 and turmeric (curcumin) slows the growth of prostate cancer in men on active surveillance.

the primary objective is to investigate the influence of vitamin d, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of nccn very low and low risk patients managed with active surveillance. this will be measured by using genomic signatures in decipher grid and using the mixed effect linear model that tests for the interaction of treatment arm and time (base-line, 6 month and 12 month time points) with gene expression as the response variable. the secondary objective is to evaluate prostate cancer aggressiveness pre and post intervention by looking at genes and gene signatures associated with vitamin d and omega-3 fatty acids pathways. prognostic performance of grid gene signatures will be evaluated using active surveillance 'failure' (deferred treatment) as an additional endpoint. the exploratory objective is to be able to use predictive genes and/or genomic signatures to assess benefit from vitamin d, omega-3 fatty acid and turmeric curcumin intake. this will only be possible once sufficient patient follow up is available.

Eligibility criteria:
inclusion criteria: * subjects must have the diagnosis of prostate cancer and be on active surveillance. for the purpose of this study, active surveillance implies prostate-specific antigen (psa)\<10 ng/ml, biopsy gleason sum \</=6 with no pattern 4 or 5, cancer involvement of \<33% of biopsy cores, and clinical stage t1/t2a tumor. * subjects must be followed at the cleveland clinic for active surveillance. * subjects must be willing to adhere to the dietary modification outlined in the protocol. * subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * subjects receiving any treatment other than as for prostate cancer. * subjects not followed by the cleveland clinic. * subjects unable to adhere to the dietary modification outlined in the protocol.

Keywords: active surveillance vitamin d omega-3 fatty acid tumeric curcumin
immunotherapy in lymphoma

Conditions: Relapsed/refractory High Grade B Cell Lymphoma; High Grade B-cell Lymphoma; Diffuse Large B Cell Lymphoma Relapsed; Primary Mediastinal Large B-Cell Lymphoma; Burkitt Lymphoma

Summary: the goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade b cell lymophoma patients. the main question it aims to answer is: does advanced immunochemotherapy, including car-t therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies? researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes. laboratory findings and electronic medical records (emr) from participants will be used to assess survival outcomes and treatment-related safety profiles.


Eligibility criteria:
inclusion criteria: * adults aged 19 to 74 years. * diagnosed with any of the following after january 2015: diffuse large b cell lymphoma, primary mediastinal large b cell lymphoma, high grade b cell lymphoma, or burkitt lymphoma * patients who have received immunochemotherapy as treatment for relapsed/refractory lymphoma exclusion criteria: * patients who have progressed to acute leukemia * patients who developed solid tumor during treatment * patients with active infectious status (acute pneumonia, viral infection, active hepatitis b state, or active pulmonary tuberculosis etc.)

Keywords: immunochemotherapy b cell lymphoma relapsed refractory
the effect of vitamin d repletion in patients with hepatocellular carcinoma on the orthotopic liver transplant list

Conditions: Vitamin D Deficiency; Hepatocellular Carcinoma

Summary: the purpose of this study is to investigate the effect of two different doses of vitamin d3 (2000 iu vs. 4000 iu) on serum 25-hydroxyvitamin d (25ohd) levels in patients with hepatocellular carcinoma on the liver transplant list. the study will help determine the dose of vitamin d3 that is required for patients with liver cancer to reach a normal level of 25ohd in the blood.

potential participants will be identified from mount sinai hospital's active liver transplant list. the hepatologists at mount sinai's transplant institute will ask each potential participant if she/he is interested in participating. if the patient expresses an interest in the study, one of the researchers will meet with the patient when the patient is at mount sinai for a regular appointment and will describe the study to the potential participant. if a patient continues to be interested in participating, she/he will be given a copy of the irb-approved consent document to read. the consent document will be used as a guide for explaining the study in detail to the patient. if the patient's preferred language is spanish, she/he will be given a consent document in spanish and the study will be explained in spanish. once the subject's 25(oh)d level is known, if the subject's 25(oh)d level is ≤ 15 ng/ml, the participant will be contacted by one of the investigators on the research team and instructed to begin taking 2 tablets per day (4000 iu total) of vitamin d. if the subject's 25(oh)d level is greater than 15 and ≤ 25, the participant will be contacted by one of the investigators on the research team and told to begin taking 1 tablet (2000 iu total) per day of vitamin d. if the participant's vitamin d level is \ 25 ng/ml they will be informed that they are not to take any vitamin d and they will be followed as controls for this study.

Eligibility criteria:
inclusion criteria: * adult patients (18 years and older) * diagnosis of hepatocellular carcinoma * on the list awaiting liver transplantation * able to give informed consent * expected to receive care following liver transplantation at the mount sinai school of medicine * any race/ethnicity/socioeconomic status exclusion criteria: * pediatric patient (less than 18 years of age) * unable to give informed consent * untreated primary hyperparathyroidism (icd9 codes 252.01xx and 252.00xx) * untreated hypercalcemia (serum calcium level \> 11 mg/dl; icd9 codes 275.42xx, 259.3xx, 252.00f) * pregnancy (will be determined by asking the patient and reviewing the medical record)

Keywords: vitamin d hepatocellular carcinoma liver neoplasms liver transplantation
trial of linaclotide in patients with irritable bowel syndrome with constipation (ibs-c)

Conditions: Irritable Bowel Syndrome With Constipation

Summary: the purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with irritable bowel syndrome with constipation (ibs-c).


Eligibility criteria:
inclusion criteria: * patient has completed a colonoscopy according to the aga criteria, with no clinically significant findings * patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ecg, or clinical laboratory tests * patient meets protocol criteria for diagnosis of ibs-c * patient demonstrates continued ibs-c through pretreatment period * patient is compliant with ivrs exclusion criteria: * patient has history of loose or watery stools * patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain * patient has a structural abnormality of the gastrointestinal (gi) tract or a disease or condition that can affect gi motility * patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Keywords: ibs
neurocutaneous melanocytosis registry

Conditions: Cutaneous Melanocytic Neoplasm; Large Cutaneous Melanocytic Nevi; Neurocutaneous Melanocytosis

Summary: this study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (lcmn) or neurocutaneous melanocytosis (ncm).


Eligibility criteria:
inclusion criteria: * patients with lcmn, defined as: * dark-colored patch of skin present at birth * can be located anywhere on the individual's skin * may include satellite lesions * may be associated with hypertrichosis or, in absence of cutaneous involvement: * histologically or radiographically confirmed cns melanocytosis. * any age at diagnosis. * signed informed consent by a patient, or parent/legal guardian. * deceased patients can be included provided that parent/legal guardian is contacted at least 6 months after the death of the child and not on the child's birthday or anniversary of death. pathology review at msk is not mandatory to confirm the diagnosis of lcmn or ncm. we will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. however, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis. exclusion criteria: * informed consent has not been provided.

Keywords: large cutaneous melanocytic nevi lcmn neurocutaneous melanocytosis ncm 20-363 memorial sloan kettering cancer center
a trial of hrs-8080 tablets in metastatic or local advanced breast cancer of adults

Conditions: Metastatic or Local Advanced Breast Cancer of Patients

Summary: the study is being conducted to evaluate the tolerance, and safety of hrs-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. to explore the reasonable dosage of hrs-8080 tablets for metastatic or local advanced breast cancer.


Eligibility criteria:
inclusion criteria: 1. ecog performance status score: 0-1; 2. histopathologically documented local advanced or metastatic breast cancer ; 3. female of not childbearing potential must the related requirement; 4. during or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation; 5. adequate organ functions as defined; 6. ability to understand and voluntarily agrees to participate by giving written informed consent for the study. exclusion criteria: 1. for the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment; 2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ; 3. history of clinically significant cardiovascular or cerebrovascular diseases; 4. the subject has one of many factors affecting oral drugs; 5. active infection or fever with unknown cause \> 38.5 °c; 6. active autoimmune diseases, history of immunodeficiency, including positive hiv serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 7. known history of allergy to study drug ingredients.
a study of multiple immune and disease treatment combinations in participants with er+her2- breast cancer that has spread

Conditions: Breast Cancer

Summary: the hypothesis of the ca048-001 phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. this study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histological and cytological confirmation of adenocarcinoma of the breast * documented her2 negative and estrogen receptor (er) positive status of primary or metastatic tumor tissue using the most recently assessed tumor specimen, according to the local laboratory parameters * er negativity is defined as \< 1% of tumor cells expressing hormonal receptors via ihc analysis * at least one measurable lesion, as per response evaluation criteria in solid tumors version 1.1 \[recist v1.1\] that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (ct) or magnetic resonance imaging (mri) * eastern cooperative oncology group (ecog) performance status of 0 or 1 * women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial exclusion criteria: * allergy or hypersensitivity to any study drugs or their excipients * any other sound medical, psychiatric and/or social reason as determined by the investigator * active, known, or suspected autoimmune disease or immune-related diseases * history of unstable or deteriorating cardiac disease within the previous 12 months prior to screening * prior therapy with anti-programmed death 1 (pd-1), anti-programmed death-ligand 1 (pd-l1) or anti-cytotoxic t lymphocyte antigen 4 (ctla-4) class antibody * any major surgery within 4 weeks of the first dose of study treatment other protocol-defined inclusion/exclusion criteria apply
retrospective assessment of ae-related healthcare resource utilization and costs of immune checkpoint inhibitor and targeted therapy for adjuvant treatment of melanoma

Conditions: Melanoma

Summary: this was a retrospective cohort study using truven health analytics' marketscan commercial claims and encounters and medicare supplement and coordination of benefit administrative claims databases. the analysis was conducted using the most recent 5 years of data from the database, 01 january 2015, to 28 february 2021 (study period). included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy \[io\] or targeted therapy \[tt\] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence of end of continuous eligibility or end of the study period.


Eligibility criteria:
inclusion criteria: * patients with at least one diagnosis of malignant melanoma of skin (the international classification of diseases, 9th revision, clinical modification \[icd-9\] codes: 172.0-172.9 or v10.82; icd-10 (10th revision) codes: c43.0 c43.10, c43.11, c43.111, c43.112, c43.12, c43.121, c43.122, c43.20, c43.21, c43.22, c43.30 c43.31 c43.39 c43.4, c43.51, c43.52, c43.59 c43.60, c43.61, c43.62, c43.70, c43.71, c43.72, c43.8 c43.9 d03.0 d03.10 d03.11, d03.111, d03.112, d03.12, d03.121, d03.122, d03.20 d03.21 d03.22 d03.30 d03.39 d03.4 d03.51 d03.52 d03.59 d03.60 d03.61 d03.62 d03.70 d03.71 d03.72 d03.8 d03.9 z85.820) anytime from the start of data collection until the start of study period. * patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the national comprehensive cancer network (nccn) guidelines version 2.2020. the first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy. * the first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma. * patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. the index date was the date of first prescription of study drug, io (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib. * at least 18 years of age at the time of adjuvant treatment initiation. * patients with at least 6 months of continuous enrollment prior to the index date. * patients with at least 6 months of continuous enrollment after the index date. exclusion criteria: * patients with a diagnosis of non-melanoma primary malignancy (icd-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; icd-10: c00.x - c14.x, c41.x, c49.x, c50, c51) during the 6 months pre-index period. * patients with chemotherapy or interferon alpha before index date. * patients with pregnancy (icd-9: 630.xx-679.xx, v22.xx-v24.xx, v27.xx-v28.xx; icd-10: o00 - o99) any time during the study period.
study to evaluate the safety, tolerability, and pharmacokinetics of mk-1029 in participants with mild to moderate asthma

Conditions: Asthma

Summary: this study will evaluate the safety, tolerability, and pharmacokinetics (pk) of multiple dose treatment with mk-1029 in adults with mild to moderate persistent asthma.


Eligibility criteria:
inclusion criteria: * if female, must be of non-childbearing potential * have a history of mild to moderate asthma for at least 6 months * other than asthma, in general good health * able to perform reproducible pulmonary function testing * is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months * have body mass index (bmi) ≥17 kg/m\^2, but ≤35 kg/m\^2 exclusion criteria: * demonstrate a decrease in absolute forced expiratory volume in 1 second (fev1) of \>20% from the screening visit to the baseline visit * experience a decrease in am or pm peak expiratory flow (pef) below the stability limit on any 2 consecutive days prior to the baseline visit * require the use of \>8 inhalations per day of short-acting beta2-agonist metered dose inhaler (mdi) or \>2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the screening visit up to the baseline visit * experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists \[saba\]) at any time from the screening visit up to the baseline visit * have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma * require the chronic use of high-dose inhaled corticosteroids * have been diagnosed with chronic obstructive pulmonary disease (copd) or any other clinically relevant lung disease, other than asthma * have a history of any illness that might confound the results of the study or poses additional risk to the participant * have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection * is nursing * have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
heart failure self-care mobile application to reduce readmissions trial

Conditions: Heart Failure

Summary: this is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. the investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.


Eligibility criteria:
inclusion criteria: * inpatient admission for acute decompensated heart failure * left ventricular systolic or diastolic heart failure * owns a smartphone with a data plan exclusion criteria: * hospice or life expectancy less than 6 months * palliative inotrope use * heart transplant listed, or status post transplant * ventricular assist devise present, or awaiting placement * not being discharged to home * unable to provide consent or comply with the intervention * current enrollment in a remote monitoring/ telehealth program

Keywords: readmission quality of life self-care
a multi-site, open-label extension trial of oral rpc1063 in relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of the trial is to determine the safety and efficacy of rpc1063 in patients with relapsing multiple sclerosis.

the trial is an open label extension study. eligible patients from the rpc01-201, rpc01-301, and rpc01-1001 trials diagnosed with relapsing multiple sclerosis (rms) will be enrolled to receive study drug until the end of the trial or until the sponsor discontinues the development program.

Eligibility criteria:
eligibility criteria: to be eligible to participate in this trial, patients must meet all of the following criteria: 1. completed one of the parent trials 2. does not have a condition that would require withdrawal from one of the parent trials 3. has no conditions requiring treatment with a prohibited concomitant medication 4. is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe: at baseline (day 1) * cyp2c8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) two weeks prior to baseline (day 1) * monoamine oxidase inhibitors (eg, selegiline, phenelzine) 5. ability to provide written informed consent and to be compliant with the schedule of protocol assessments 6. female patients of childbearing potential: must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day safety follow-up visit. highly effective methods of contraception are those that alone or in combination result in a failure rate of a pearl index of less than 1% per year when used consistently and correctly. acceptable methods of birth control in this study are the following: * combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable * placement of an intrauterine device (iud) * placement of an intrauterine hormone-releasing system (ius) * bilateral tubal occlusion * vasectomised partner * sexual abstinence. exclusion criteria:

Keywords: ms rms multiple sclerosis relapsing multiple sclerosis
relation between adverse reactions to food, physical performance and health in a mediterranean population

Conditions: Food Allergy; Food Intolerance; Adverse Reaction to Food

Summary: since the prevalence of adverse reactions to foodstuffs (arfs) has been steadily increasing and has become an alarming health concern, the general objective of this study is to analyze the prevalence of arfs in spanish adults of different physical condition.

individuals with associated diseases and symptomatology to arfs will be selected and will be clinically and physically measured.

Eligibility criteria:
inclusion criteria: * diseases and symptomatology associated to arf. exclusion criteria: * participation in other study. * pregnancy. * antibiotic treatment. * active helicobacter pylori infection. * antidepressant, sleeping pill, or anxiolytic treatment. * job or lifestyle that potentially interferes with your regular sleep schedule. * active cancer treatment.